The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

NCT ID: NCT05272475

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2022-05-12

Brief Summary

Chamomile may possess anticoagulant effects based on the presence of coumarin-like compounds within the flower. This randomized complete crossover study will investigate the impact of chamomile ingestion acutely on coagulation.

Detailed Description

Subjects will be enrolled into two groups in a crossover fashion upon obtaining written informed consent. The two intervention groups include (1) chamomile tea intake and (2) chamomile extract intake. Subjects will consume a single preparation of chamomile tea or extract capsule, and partake in a minimum of three days washout period between interventions. Screening assays of coagulation will be obtained immediately before the ingestion of chamomile, two hours after ingestion, and four hours after ingestion over the course of a single day.

Conditions

Coagulation Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Chamomile Tea

Subjects will consume a single serving of chamomile tea on the visit day. The tea serving will be prepared using 3 grams of chamomile tea steeped in hot water according to the study protocol.

Group Type: EXPERIMENTAL

Chamomile Tea

Intervention Type: DIETARY_SUPPLEMENT

Chamomile tea bags consumed by subjects as described in study arms section.

Chamomile Extract Capsule

Subjects will consume a single chamomile capsule on the visit day. Each capsule consists of 500 milligrams of a chamomile extract that has been standardized to 1.2% apigenin content.

Group Type: EXPERIMENTAL

Chamomile Extract Capsule

Intervention Type: DIETARY_SUPPLEMENT

Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.

Interventions

Chamomile Tea

Chamomile tea bags consumed by subjects as described in study arms section.

Intervention Type: DIETARY_SUPPLEMENT

Chamomile Extract Capsule

Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Able to provide informed written consent
• Able to withhold use of other chamomile products (teas, lotions, supplements, extracts); will only use study-supplied chamomile products for duration of study
• Able to withhold intake of solid food at least 6 hours before intake of the chamomile preparation
• Able to withhold intake of clear liquids at least 2 hours before intake of the chamomile preparation

Exclusion Criteria

• Past medical/family history of bleeding/thrombotic disorders (e.g. hemophilia, von-Willebrand disease)
• Chronic medications known to affect hemostasis (anticoagulants, antiplatelet agents, SSRIs, herbal/complementary medicine agents)
• Three or more alcoholic drinks daily
• Sedentary status/ restricted mobility
• Active smoker or quit smoking within one week of study period
• Females who are pregnant, breast-feeding, or lactating
• History of estrogen-dependent condition such as uterine fibroids, breast cancer, uterine cancer, or ovarian cancer
• Scheduled surgical procedure during study period
• Hospitalized patients
• Underweight (BMI < 18 kg/m2) or history of malnourishment
• Active symptoms of a respiratory, dermatologic, urinary, or gastrointestinal infection
• Diagnosed allergy to chamomile
• Severe allergy to ragweed
• Physical inability to consume chamomile tea according to the study dosing schedule
• Prescription usage of an anticoagulant agent such as warfarin, anti-Xa inhibitor, or other novel oral anticoagulants
• ADP antagonist use, including clopidogrel, prasugrel, and ticagrelor
• GPIIb/IIIa inhibitor use, including ticlopidine, eptifibatide
• More than weekly NSAID use (e.g. aspirin, ibuprofen, naproxen)
• Diagnosis of a bleeding-diathesis disorder
• Diagnosis of a hypercoagulable state
• History of elevated INR or other abnormal bleeding study (PT, aPTT, thrombin time, reptilase time, above the upper limit of normal for Stony Brook Hospital Reference Range) while not taking anticoagulants or herbal supplements listed below
• Active intake of the following herbal supplements at time of study enrollment that may alter baseline coagulation function including:

• Ginger
• Garlic
• Gingko
• Ginseng
• Fish oil
• Black Cohosh
• Feverfew
• Valerian
• Coenzyme Q10
• Goldenseal
• St. John Wort
• Active intake of chamomile extracts or teas at time of study enrollment
• Inability to discontinue the aforementioned herbal supplements more than 14 days before enrollment into the study
• Significant fear of needles or fainting blood draws
• Actively taking cyclosporine
• Patient refusal to participate in study for the allotted study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Jonathon Schwartz

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

References

Kimura R, Schwartz JA, Romeiser JL, Senzel L, Galanakis D, Halper D, Bennett-Guerrero E. The Acute Effect of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers: A Randomized Trial. J Appl Lab Med. 2024 May 2;9(3):468-476. doi: 10.1093/jalm/jfad120.

Reference Type: DERIVED

PMID: 38300838 (View on PubMed)

Other Identifiers

IRB2022-00036

Identifier Type: -

Identifier Source: org_study_id